Experience

• Head of Medical Writing
  at Healthcare Project Management (HPM) Geneva

Over four years, I built from scratch a writing team of 5 high calibre scientists and I was responsible for the department’s profit and loss.
I supervised and contributed to over 50 Common Technical Documents (CTDs) incl. new drug applications, type-II variations and reclassifications (Rx to OTC switch) for a variety of indications and drugs, ranging from those with orphan status to those of well-established use. I was also actively involved in about 20 publications and various other projects such as study protocols/reports, Risk Management Plans and late-stage safety analyses, brochures, IMPDs, INDs, development plans, and Due Diligence dossiers.
I regularly liaised with key clients from Regulatory Affairs and Medical Communication departments as well as with key opinion leaders (KOL) and investigators. Based on provided conceptual input or statistical analyses,
I co-authored several publications of investigator-initiated oncology trials
(e.g. PFAD, CAR) as well as of  academic research on diagnostics and pharmacoeconomics.

• Scientific Director
  at MDS Pharma Services Central Laboratory Hamburg

I was responsible for the set up and validation of new analytical procedures, and for the routine testing of biological samples according to study protocols and the principles of Good Laboratory Practice (GLP).
I provided scientific support to internal departments and responded to scientific questions from clients and Health Authorities. Further routine tasks were the writing and reviewing of SOPs, validation and analytical reports, and I initiated and authored a peer-reviewed publication on how to avoid frozen transports for the global testing of haemostasis in safety trials.

• Postdoc Scientist
  in Vienna and Wilhelmshaven

Before joining the industry, I worked as a Post-doc at the University of Vienna, Austria, and the Institute of Avian Research in Wilhelmshaven, Germany, on diverse research topics. During my last year in academic research, I was involved in an EU project on early onset symptoms of Creutzfeldt-Jacob’s Disease and its relatedness to the Mad Cow Disease. Previously, I had investigated endocrine body mass control and glucostasis in an avian animal model for obesity and type II diabetes. I also co-authored scientific articles in the fields of ecophysiology and physiotherapy.

For further details and a complete publication list please see my Curriculum Vitae.